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510(k) K991828

STREP B OIA by Biostar, Inc. — Product Code GTY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 19, 1999
Date Received
May 28, 1999
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Antigens, All Groups, Streptococcus Spp.
Device Class
Class I
Regulation Number
866.3740
Review Panel
MI
Submission Type

Other clearances by Biostar, Inc.

  • K991829 — CDTOX A OIA (November 2, 1999)
  • K981651 — AB FLU OIA (November 25, 1998)
  • K962060 — STREP A OIA MAX (July 23, 1997)
  • K951010 — CHLAMYDIA OIA (October 7, 1995)
  • K936112 — STREP B OIA (July 6, 1994)

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